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Triplex Real-time PCR Detection Kit for Group A Rotavirus / Norovirus GI / Noro…
EUDAMEDClass IVD General (EU MDR)
Ref A2593YH
Identity
- Device Name
- Triplex Real-time PCR Detection Kit for Group A Rotavirus / Norovirus GI / Norovirus GII EUDAMED
- Model / Reference
- A2593YH EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974323011354 EUDAMED06974323011361 EUDAMED
- Basic UDI-DI
- B-06974323011354 EUDAMEDB-06974323011361 EUDAMED
- EMDN Code
- W0105070504 GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Triplex Real-time PCR Detection Kit for Group A Rotavirus / Norovirus GI / Noro… by Beijing Applied Biological Technologies Co., Ltd. — Class IVD General…
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06974323011354 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Beijing Applied Biological Technologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000012338
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (2)
- EUDAMED 33839a13-255b-48c7-8e33-a1f4926e8b90 61 fields · synced Jul 10, 2026
- EUDAMED 721163fa-372d-42db-9ff7-b6cd0142157e 61 fields · synced May 18, 2026